Massive Rotator Cuff TearsNCT07154641
Latissimus Dorsi Tendon Transfer vs. Superior Capsular Reconstruction in Massive Rotator Cuff Tears
A study testing Latissimus dorsi tendon transfer and Superior capsular reconstruction in people with Massive Rotator Cuff Tears, run by Konstantopoulio-Patission General Hospital of Nea Ionia at 1 site in Greece.
Trial summary
The goal of this clinical trial is to compare the results of two surgical operations for the treatment of massive rotator cuff tears: latissimus dorsi tendon transfer (LDT) and superior capsular reconstruction (SCR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Massive Rotator Cuff Tears
- What is being tested?
- Latissimus dorsi tendon transfer and Superior capsular reconstruction
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGreece
- Study dates
- 2 Jul 2025to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (over 18 years old). Massive rotator cuff tear diagnosis based on shoulder MRI. -
Who cannot join
- Advanced glenohumeral arthritis (Hamada ≥3). Deltoid dysfunction. Irrepearable subscapularis tear. Infection. Prior shoulder surgery. Shoulder stiffness.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Konstantopouleio-Patision General Hospital of Nea Ionia
Athens, Attica, 14233
Dimitrios V Papadopoulos, MD, PhD, +306976016874, di_papadopoulos@yahoo.gr
Athanasios Kontogiannis, MD
About this study
Official title: Comparison Between Latissimus Dorsi Tendon Transfer and Superior Capsular Reconstruction in Massive Rotator Cuff Tears: A Randomised Controlled Trial.
The goal of this clinical trial is to compare the results of two surgical operations for the treatment of massive rotator cuff tears: latissimus dorsi tendon transfer (LDT) and superior capsular reconstruction (SCR).
The main question it wants to answer is which of the two operations provides better functional results, as measured by two patient-reported questionaires: the American Shoulder and Elbow Surgeons (ASES) score and the Constant-Murley score.
The patients will be randomly assigned to one of two groups according to the surgery they will undergo (LDT or SCR). They will be examined clinically and asked to fill the questionaires before the surgery, at 6 weeks and at 3, 6, 12 and 24 months after surgery.
Read the detailed description
The participants will be included in the research protocol by Mai 2025. The sample size is determined through a power analysis based on the postoperative Constant scores of a similar trial after 31 months of follow-up (see References). Τhe mean difference between preoperative and postoperative Constant scores was used to calculate sample size with a power of 80% and a=0.05. A two-tailed test was used for two independent mean values with effect size d=0.8841. According to the power analysis, 22 patients are required for each cohort (44 patients in total) to achieve a statistically significant difference between mean preoperative and postoperative Constant scores. The critical t value was 2.018 for 42 degrees of freedom. The authors used the Shapiro-Wilk test to confirm the normal distribution of the data. The power analysis was conducted using the G*power 3.1 software. Enrolled patients will be randomized into two treatment cohorts by a member of the research team who will be blinded to the preoperative patient data, with randomization software. 22 patients will undergo latissimus dorsi tendon transfer (LDT) and 22 patients will undergo superior capsular reconstruction (SCR).
Primary outcomes include the Constant score, the American Shoulder and Elbow Surgeons (ASES) score, and the Visual Analog Scale (VAS) for pain assessment. Secondary outcomes include the progression to osteoarthritis, the measurement of the acromiohumeral distance (AHD) and the treatment of pseudoparalysis.
The patients will be physically examined before surgery, at 6 weeks and at 3 months, 6 months, 12 months and 24 months after surgery. During follow-ups in 3, 6, 12 and 24 months postoperatively, patients will be physically examined by a member of the research team who will be blinded to the type of surgery.
To assess active range of motion (ROM) in forward flexion, abduction, internal and external rotation, a typical goniometer will be used. Patients should be upright with the scapula stabilised in the vertical plane. Additionally, muscle strength will be assessed using a handheld dynamometer. Patients will fill in the Constant, ASES and VAS questionnaires in each follow-up. Moreover, in 2, 12 and 24 months after surgery anterior-posterior radiographs will be performed. Radiographs will be assessed for the progression of rotator cuff arthropathy (based on the Hamada classification) and the AHD will be measured by a radiologist who will be blinded to the type of surgery.
- Conditions
- Massive Rotator Cuff Tears
- Being tested
- Latissimus dorsi tendon transfer, Superior capsular reconstruction
- Keywords
- Massive rotator cuff tears, Latissimus dorsi tendon transfer, Superior capsular reconstruction, rotator cuff tears
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latissimus dorsi tendon transferProcedure or surgery
Latissimus dorsi tendon transfer is a surgical procedure that aims to restore active range of motion and stability of the shoulder in patients with massive rotator cuff tears. The tendon of the latissimus dorsi muscle is dettached from its insertion in the midbicipital groove of the humerus and reattached to the greater tubetosity. Therefore, the muscle acts as an external rotator, while the forces created pull the humeral head down and stabilize it in the glenoid.
Superior capsular reconstructionProcedure or surgery
Superior capsular reconstruction is a surgical procedure that aims to restore shoulder stability in patients with massive rotator cuff tears. The superior capsule of the shoulder joint is attached to the greater tuberosity and is therefore often torn in cases of supraspinatus or infraspinatus tears. A fascia lata autograft is used to reconstruct the torn capsule, between the greater tuberosity and the glenoid. Thus, superior migration of the humeral head is prevented, and pain and functionality are improved.
| Study group | Role | What they receive |
|---|---|---|
| Latissimus dorsi tendon transfer group | Active comparator | 22 patients are expected to undergo latissimus dorsi tendon transfer for the treatment of massive rotator cuff tears Receives: Procedure: Latissimus dorsi tendon transfer |
| Superior capsular reconstruction group | Active comparator | 22 patients are expected to undergo superior capsular reconstruction for the treatment of massive rotator cuff tears. Receives: Procedure: Superior capsular reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant-Murley score
Functionality will be measured based on the Constant-Murley score. This questionaire includes 4 sections, regarding pain, activities of daily living (ADL), range of motion (ROM) and muscle strength. The questions regarding pain and ADL are filled by the patients, whereas the assessment of ROM and muscle strength require physical examination by a member of the research team. For the assessment of strength a handheld dynamometer will be used. The minimum score is 0 and the maximum 100.
Measured: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.
American Shoulder and Elbow Surgeons (ASES) score
American Shoulder and Elbow Surgeons (ASES) score, measures functionality of the shoulder. It includes 17 multiple-choice questions which are filled by the patients and is divided in two sections: one section about pain assessment and one about activities of daily living (ADL). The minimum score is 0 and the maximum 100.
Measured: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.
Visual Analog Scale (VAS) for pain
The Visual Analog Scale for pain is a scale from 0 to 10, that measures the intensity of pain and is a patient-reported score. 0 means "no pain at all" and 10 "pain as bad as it can be". The scale is included in the Pain Questionaire of the American Shoulder and Elbow Surgeons (ASES) score.
Measured: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.
Active Range of Motion (ROM)
The active Range of Motion (ROM) will be measured before and after surgery and compared between the two arms. The participants will be examined clinically by an investigator who will be blinded to the type of surgery. The active ROM in forward flexion, abduction, internal and external roation of the shoulder will be examined. For this purpose, a typical goniometer will be used. During the examination the patients should be standing and the scapula should be stabilised in the vertical plane.
Measured: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.
Muscle strength
Muscle strength will be measured using a hand dynamometer. This is included in the last section of the Constant-Murley score. Minimum score is 0 and maximum is 25. The score is calculated as 1 point per pound or 2.2 points per kilogram. The patient should hold the weight with the arm in 90° of abduction and the elbow extended for at least 3 seconds. Three consecutive measurements are performed with at least 1 minute break in between. The measurement with the best score defines the overall score. If the patients are unable to abduct the arm 90° or if they are experiencing pain, the score is 0.
Measured: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.
Secondary outcomes (2)
Treatment of Pseudoparalysis
Pseudoparalysis is defined as inability of forward flexion at 90°, with absence of neurological deficit, and maintained passive range of motion (ROM). Patients will be examined clinically for the progression or treatment of pseudoparalysis and the results will be compared between the two arms.
Measured: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.
Progression of Rotator Cuff Arthropathy
The progression of rotator cuff arthropathy will be assessed. by a radiologist who will be blinded to the type of treatment. Radiographs will be taken at 2, 12 and 24 months after surgery and the progression of osteoarthritis will be examined based on the Hamada classification (grade I to V). The acromiohumeral distance will also be measured in each radiograph. The results will be compared between the two arms.
Measured: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start2 Jul 2025
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Massive Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konstantopoulio-Patission General Hospital of Nea Ionia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios V Papadopoulos, Konstantopoulio-Patission General Hospital of Nea Ionia
- Investigators
- Dimitrios V Papadopoulos, MD, PhD, Principal investigator, Second Department of Orthopaedics, Medical School, National and Kapodistrian University of Athens, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154641
- Sponsor's protocol ID
- 102/13-3-25
- Status last verified
- Aug 2025
- First submitted
- 6 Jul 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ozturk BY, Ak S, Gultekin O, Baykus A, Kulduk A. Prospective, randomized evaluation of latissimus dorsi transfer and superior capsular reconstruction in massive, irreparable rotator cuff tears. J Shoulder Elbow Surg. 2021 Jul;30(7):1561-1571. doi: 10.1016/j.jse.2021.01.036. Epub 2021 Mar 4.
PubMed 33675971
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Latissimus Dorsi Tendon Transfer and Superior Capsular Reconstruction in Massive Rotator Cuff Tears: A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT07154641
- Acronym / sponsor ID
- 102/13-3-25
- Conditions
- Massive Rotator Cuff Tears
- Keywords
- Massive rotator cuff tears, Latissimus dorsi tendon transfer, Superior capsular reconstruction, rotator cuff tears
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Konstantopoulio-Patission General Hospital of Nea IoniaUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the results of two surgical operations for the treatment of massive rotator cuff tears: latissimus dorsi tendon transfer (LDT) and superior capsular reconstruction (SCR).
The main question it wants to answer is which of the two operations provides better functional results, as measured by two patient-reported questionaires: the American Shoulder and Elbow Surgeons (ASES) score and the Constant-Murley score.
The patients will be randomly assigned to one of two groups according to the surgery they will undergo (LDT or SCR). They will be examined clinically and asked to fill the questionaires before the surgery, at 6 weeks and at 3, 6, 12 and 24 months after surgery.
Detailed description
The participants will be included in the research protocol by Mai 2025. The sample size is determined through a power analysis based on the postoperative Constant scores of a similar trial after 31 months of follow-up (see References). Τhe mean difference between preoperative and postoperative Constant scores was used to calculate sample size with a power of 80% and a=0.05. A two-tailed test was used for two independent mean values with effect size d=0.8841. According to the power analysis, 22 patients are required for each cohort (44 patients in total) to achieve a statistically significant difference between mean preoperative and postoperative Constant scores. The critical t value was 2.018 for 42 degrees of freedom. The authors used the Shapiro-Wilk test to confirm the normal distribution of the data. The power analysis was conducted using the G*power 3.1 software. Enrolled patients will be randomized into two treatment cohorts by a member of the research team who will be blinded to the preoperative patient data, with randomization software. 22 patients will undergo latissimus dorsi tendon transfer (LDT) and 22 patients will undergo superior capsular reconstruction (SCR).
Primary outcomes include the Constant score, the American Shoulder and Elbow Surgeons (ASES) score, and the Visual Analog Scale (VAS) for pain assessment. Secondary outcomes include the progression to osteoarthritis, the measurement of the acromiohumeral distance (AHD) and the treatment of pseudoparalysis.
The patients will be physically examined before surgery, at 6 weeks and at 3 months, 6 months, 12 months and 24 months after surgery. During follow-ups in 3, 6, 12 and 24 months postoperatively, patients will be physically examined by a member of the research team who will be blinded to the type of surgery.
To assess active range of motion (ROM) in forward flexion, abduction, internal and external rotation, a typical goniometer will be used. Patients should be upright with the scapula stabilised in the vertical plane. Additionally, muscle strength will be assessed using a handheld dynamometer. Patients will fill in the Constant, ASES and VAS questionnaires in each follow-up. Moreover, in 2, 12 and 24 months after surgery anterior-posterior radiographs will be performed. Radiographs will be assessed for the progression of rotator cuff arthropathy (based on the Hamada classification) and the AHD will be measured by a radiologist who will be blinded to the type of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Latissimus dorsi tendon transfer group | Active comparator | Procedure: Latissimus dorsi tendon transfer22 patients are expected to undergo latissimus dorsi tendon transfer for the treatment of massive rotator cuff tears |
| Superior capsular reconstruction group | Active comparator | Procedure: Superior capsular reconstruction22 patients are expected to undergo superior capsular reconstruction for the treatment of massive rotator cuff tears. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (over 18 years old). Massive rotator cuff tear diagnosis based on shoulder MRI. -
Key exclusion criteria (2 listed)
- Advanced glenohumeral arthritis (Hamada ≥3). Deltoid dysfunction. Irrepearable subscapularis tear. Infection. Prior shoulder surgery. Shoulder stiffness.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Latissimus dorsi tendon transferLatissimus dorsi tendon transfer is a surgical procedure that aims to restore active range of motion and stability of the shoulder in patients with massive rotator cuff tears. The tendon of the latissimus dorsi muscle is dettached from its insertion in the midbicipital groove of the humerus and reattached to the greater tubetosity. Therefore, the muscle acts as an external rotator, while the forces created pull the humeral head down and stabilize it in the glenoid. | Procedure or surgery | Latissimus dorsi tendon transfer group |
| Superior capsular reconstructionSuperior capsular reconstruction is a surgical procedure that aims to restore shoulder stability in patients with massive rotator cuff tears. The superior capsule of the shoulder joint is attached to the greater tuberosity and is therefore often torn in cases of supraspinatus or infraspinatus tears. A fascia lata autograft is used to reconstruct the torn capsule, between the greater tuberosity and the glenoid. Thus, superior migration of the humeral head is prevented, and pain and functionality are improved. | Procedure or surgery | Superior capsular reconstruction group |
Primary outcome
Constant-Murley score
Time frame: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.
Functionality will be measured based on the Constant-Murley score. This questionaire includes 4 sections, regarding pain, activities of daily living (ADL), range of motion (ROM) and muscle strength. The questions regarding pain and ADL are filled by the patients, whereas the assessment of ROM and muscle strength require physical examination by a member of the research team. For the assessment of strength a handheld dynamometer will be used. The minimum score is 0 and the maximum 100.
American Shoulder and Elbow Surgeons (ASES) score
Time frame: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.
American Shoulder and Elbow Surgeons (ASES) score, measures functionality of the shoulder. It includes 17 multiple-choice questions which are filled by the patients and is divided in two sections: one section about pain assessment and one about activities of daily living (ADL). The minimum score is 0 and the maximum 100.
Visual Analog Scale (VAS) for pain
Time frame: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.
The Visual Analog Scale for pain is a scale from 0 to 10, that measures the intensity of pain and is a patient-reported score. 0 means "no pain at all" and 10 "pain as bad as it can be". The scale is included in the Pain Questionaire of the American Shoulder and Elbow Surgeons (ASES) score.
Active Range of Motion (ROM)
Time frame: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.
The active Range of Motion (ROM) will be measured before and after surgery and compared between the two arms. The participants will be examined clinically by an investigator who will be blinded to the type of surgery. The active ROM in forward flexion, abduction, internal and external roation of the shoulder will be examined. For this purpose, a typical goniometer will be used. During the examination the patients should be standing and the scapula should be stabilised in the vertical plane.
Muscle strength
Time frame: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.
Muscle strength will be measured using a hand dynamometer. This is included in the last section of the Constant-Murley score. Minimum score is 0 and maximum is 25. The score is calculated as 1 point per pound or 2.2 points per kilogram. The patient should hold the weight with the arm in 90° of abduction and the elbow extended for at least 3 seconds. Three consecutive measurements are performed with at least 1 minute break in between. The measurement with the best score defines the overall score. If the patients are unable to abduct the arm 90° or if they are experiencing pain, the score is 0.
2 secondary outcomes
Treatment of Pseudoparalysis
Time frame: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.
Progression of Rotator Cuff Arthropathy
Time frame: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Background: PubMed 33675971Ozturk BY, Ak S, Gultekin O, Baykus A, Kulduk A. Prospective, randomized evaluation of latissimus dorsi transfer and superior capsular reconstruction in massive, irreparable rotator cuff tears. J Shoulder Elbow Surg. 2021 Jul;30(7):1561-1571. doi: 10.1016/j.jse.2021.01.036. Epub 2021 Mar 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dimitrios V Papadopoulos, MD, PhD principal investigator
Second Department of Orthopaedics, Medical School, National and Kapodistrian University of Athens, Athens, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Latissimus dorsi tendon transfer and Superior capsular reconstruction in people with Massive Rotator Cuff Tears, run by Konstantopoulio-Patission General Hospital of Nea Ionia at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dimitrios V Papadopoulos, MD, PhD (+306976016874, di_papadopoulos@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant-Murley score (time frame: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07154641, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.